Drug factory · FDA FEI 3006799640
Frontage Laboratories, Inc.
760 Pennsylvania Dr, Exton, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
14 drug inspections on record since 2009: 10 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dordaviprone | Tests it | Jazz Pharmaceuticals, Inc. | 68727-250 |
| Oritavancin | Tests it | Melinta Therapeutics, LLC | 70842-140, 70842-225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2026 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Apr 14, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 5, 2025 | No problems found | Bioresearch Monitoring | — |
| Mar 31, 2023 | No problems found | Bioresearch Monitoring | — |
| Oct 15, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 1, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2018 | No problems found | Bioresearch Monitoring | — |
| Mar 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 30, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 17, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 5, 2011 | No problems found | Drug Quality Assurance | — |
| Mar 19, 2010 | No problems found | Drug Quality Assurance | — |
| Apr 7, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 14, 2026 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. - Data secured in course of each test 21 CFR 211.194(a)(4)
Laboratory records do not include a complete record of all data secured in the course of each test, including all charts and spectra from laboratory instrumentation, properly identified to show the. - Backup file not maintained 21 CFR 211.68(b)
Failure to maintain a backup file of data entered into the computer or related system.
Registered with FDA for: analysis.